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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, C12-18(even numbered)-alkyldimethyl, N-oxides
EC Number:
931-341-1
Cas Number:
68955-55-5
Molecular formula:
CnH(2n+3)NO, where n=14-20
IUPAC Name:
Amines, C12-18(even numbered)-alkyldimethyl, N-oxides
Details on test material:
Name of test material: Hoe S 3406
Composition: 30 % AO in water, < 0.3 % free fatty alcohol, <0.5 % free amine, < 0.1 % hydrogen peroxide
Lot No. E 06201864

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: no data
- Weight at study initiation: 2.6-3.4 kg
- Housing:no data
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/- 10
- Air changes (per hr): air conditioned room, no data
- Photoperiod (hrs dark / hrs light): 12 hours light/dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 30 % w/v

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage:
- Type of wrap if used: semi-occlusive binding, no further details

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no description of method
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24, 48 & 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 48 & 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 48 & 72 hours
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 48 & 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24, 48 & 72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The C12-18 AO is a skin irritant in this study.